Recall Z-0679-06 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Baxter Healthcare Renal Div
Baxter BM25 System ultrafiltration hemodialysis machine; The BM25 System is composed of a BM11A Blood Monitor Pump (5M3051/5M3051R) and a BM14 Ultrafiltration Monitoring Module (5M3052/5M3052R), with a cart with scales (5M3053); Baxter Healthcare Corporation, Deerfield, IL 60015; product code GEF042-10 in China
| Date | Mar 29, 2006 (initiated Dec 21, 2005) |
| Status | Terminated |
| Reason | Advisory to alert users to assure that the hemofilter of the blood line is in the horizontal position to avoid kinking of the bloodline tubing to avoid hemolysis, and to show the compatible blood tubing sets to be used with the BM11/BM11A Blood Monitor Pump and BM25 System ultrafiltration hemodialysis system. |
| Root cause | Other |
| Action | Important Product Information letters dated 12/21/05 were sent to all BM-series instrument users, informing them of the potential for kinking of the tubing if the hemofilter is in the vertical position and the compatibility testing conducted on certain blood tubing sets for use with the BM-series instruments and Baxter''s recommendation that the following sets be used with the BM-series instruments: a) product code 5M3006M for use with the BM 11 and the BM 11a, when the BM 11a is used as a stand alone device; b) product code 5M3048 for use with the BM 11a when operated as part of the BM 25 Sys |
| Quantity | 409 units |
| Distribution | Nationwide including Puerto Rico, and internationally to Colombia, Hong Kong and China |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K974652 | BLOOD MONITOR PUMP WITH ULTRAFILTRATION CONTROLLER Baxter Healthcare Corp, Jul 10, 1998 |